Laboratory system

ABSTRACT

A laboratory system is disclosed. The laboratory system comprises a plurality of laboratories comprising one or more analytical instruments for performing a plurality of analytical tests (T 1 - n ) and providing analytical test results (TR 1 - n ) and a remote computer communicatively connected to the laboratories. Each of the laboratories is configured to define test result validation criteria (C 1 - n ) for validating at least one of the analytical test results (TR 1 - n ) associated with the respective analytical tests (T 1 - n ) of one of the plurality of laboratories. The remote computer is configured to define a plurality of profiles (P 1 - n ) of validation criteria, to assign the profiles (P 1 - n ) of test result validation criteria (C 1 - n ) to one or more of the laboratories ( 102 ), and to perform an automatic validation of groups (G 1 - n ) of the analytical test results (TR 1 - n ) according to the profiles (P 1 - n ) of test result validation criteria (C 1 - n ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of EP 17382400.4 filed Jun. 27, 2017,which is hereby incorporated by reference.

BACKGROUND

The present disclosure generally relates to a laboratory system.

A Laboratory Information System (LIS) provides an essential supportregarding managing test requests, receiving results and validating themin an efficient manner especially in the typical situation where a usermight have distributed laboratories across several locations, this isthe case when working in a multi-site environment.

One of the challenges faced by an LIS in a multi-site environment is thedifficulties that are presented to a user when he needs to performvalidation of different groups of test results with different validationcriteria. In multi-site environments, the difficulty increases as thereis need to create multiple configurations depending on the number oflocations covered by the system. Thus, at each location, tests groupingis different and the validation criterion applied to each of thosegroups is also different.

Another of the challenges connected to a multi-site logic within a LISis also to keep the performance of the system independent of themultiple configurations that are intrinsic to a multisite environment.

Therefore, there is a need to create profile logic within a validationworkflow.

SUMMARY

According to the present disclosure, a laboratory system is presented.The laboratory system can comprise a plurality of laboratories. Eachlaboratory can comprise one or more analytical instruments forperforming a plurality of analytical tests (T1-n) of biological samplesand providing analytical test results (TR1-n). Each of the laboratoriescan be configured to define test result validation criteria (C1-n) forvalidating at least one of the analytical test results (TR1-n)associated with the respective analytical tests (T1-n) of one of theplurality of laboratories. The laboratory system can also comprise aremote computer communicatively connected to the laboratories via acommunication network. The remote computer can be configured to define aplurality of profiles (P1-n) of validation criteria. Each profile (P1-n)can comprise a plurality of test result validation criteria (C1-n), apredetermined grouping (G1-n) of the plurality of analytical tests(T1-n) and a validation group flag (F1-n) indicating a group (G1-n) ofanalytical test results (TR1-n) to be validated. The remote computer canbe configured to assign the profiles (P1-n) of test result validationcriteria (C1-n) to one or more of the plurality of laboratories (102).The remote computer can be configured to perform an automatic validationof groups (G1-n) of the analytical test results (TR1-n) according to theprofiles (P1-n) of test result validation criteria (C1-n) by setting thevalidation group flag (F1-n) to the groups (G1-n) of analytical testresults (TR1-n) to be validated and validating the groups (G1-n) ofanalytical test results (TR1-n) onto which the validation group flag(F1-n) is set based on the test result validation criteria (C1-n).

Accordingly, it is a feature of the embodiments of the presentdisclosure to create profile logic within a validation workflow. Otherfeatures of the embodiments of the present disclosure will be apparentin light of the description of the disclosure embodied herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following detailed description of specific embodiments of thepresent disclosure can be best understood when read in conjunction withthe following drawings, where like structure is indicated with likereference numerals and in which:

FIG. 1 illustrates a laboratory system according to an embodiment of thepresent disclosure.

FIG. 2 illustrates an example for profiles of validation criteriaaccording to an embodiment of the present disclosure.

FIG. 3 illustrates examples for the allocation of validation criteria towork areas according to an embodiment of the present disclosure.

FIG. 4 illustrates a block diagram of a method carried out by thelaboratory system according to an embodiment of the present disclosure.

FIG. 5 illustrates a swim line diagram of a method for validating agroup of analytical test results of a plurality of analytical tests ofbiological samples performed by analytical instruments of a plurality oflaboratories according to an embodiment of the present disclosure.

FIGS. 6-10 illustrate respectively diagrams of sub-steps of the methodof FIG. 5 according to an embodiment of the present disclosure.

FIGS. 11-13 illustrate respectively further embodiments of the method ofFIG. 5 according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

In the following detailed description of the embodiments, reference ismade to the accompanying drawings that form a part hereof, and in whichare shown by way of illustration, and not by way of limitation, specificembodiments in which the disclosure may be practiced. It is to beunderstood that other embodiments may be utilized and that logical,mechanical and electrical changes may be made without departing from thespirit and scope of the present disclosure.

A laboratory system can comprise a plurality of laboratories. Eachlaboratory can comprise one or more analytical instruments forperforming a plurality of analytical tests of biological samples andproviding analytical test results. The laboratory system can alsocomprise a remote computer communicatively connected to the laboratoriesvia a communication network. Each of the laboratories can be configuredto define test result validation criteria for validating at least one ofthe analytical test results associated with the respective analyticaltests of one of the plurality of laboratories. The remote computer canbe configured to define a plurality of profiles of validation criteria.Each profile can comprise a plurality of the test result validationcriteria, a predetermined grouping of the plurality of analytical testsand a validation group flag indicating a group of analytical testresults to be validated. The remote computer can be configured to assignthe profiles of validation criteria to one or more of the plurality oflaboratories. The remote computer can be configured to perform anautomatic validation of groups of the analytical test results accordingto the profiles of validation criteria by setting the validation groupflag to the groups of analytical test results to be validated andvalidating the groups of analytical test results onto which thevalidation group flag can be set based on the test result validationcriteria.

In multi-site environments for laboratories, each of the laboratoriescan be allowed to “design” or define its own validation criteria oflaboratory test results. For example, for one or more analytical testresults, a laboratory may define a validation criterion as appropriate.In other words, the validation criteria may be suitably adapted oradjusted by each laboratory. Thus, the validation criteria can bedefined by the laboratories according to their expertise which canincrease the quality of the validation results. However, with increasingsize of such multi-site environments, a centralized control of results,validation and reporting can become very complex.

In order to address such challenges, some embodiments disclosed hereincan make use of a remote computer configured to define a plurality ofprofiles of validation criteria. Each profile can comprise a pluralityof the test result validation criteria, a predetermined grouping of theplurality of analytical tests and a validation group flag indicating agroup of analytical test results to be validated. In other words, theremote computer can be used to take the validation criteria defined bythe respective laboratories, to provide a certain grouping of therespective analytical tests and to provide a marker for those analyticaltests results, which are to be validated, in order to create one or moreprofiles. These profiles can then be used for the validation of thegroups of the analytical test results based on the test resultvalidation criteria defined by the laboratories. Accordingly, contraryto a validation of each single analytical test result as known in theart, according to embodiments disclosed herein—a plurality of analyticaltest results can be validated as a group(s) based on test resultvalidation criteria defined according to the requirements and expertiseof the respective laboratories. Thus, the laboratory system can increasethe throughput of validation processes per time and can also reduce therisks of user error, thereby providing consistency in the validation oftest results across multiple laboratories.

The disclosed laboratory system can allow the creation of a “profile ofvalidation criteria” which may comprise of a triad group of “validationcriteria—test group—validate as a group”. That is, an associationbetween a given set of tests may be defined, a test result validationcriteria specific and different from those used for other tests groupand a flag setting if the group of tests has to be validated as oneitem, such as tests of the group will be validated only if all tests canbe validated, or test by test. Then some of these associations “triads”of “test groups”, “test result validation criteria” and “validate as agroup flag” may be grouped under the “profile of validation criteria”.Finally, the laboratory system can allow the assignment of these“profiles of validation criteria” to each of the existing locations inorder to allow system to perform an automatic validation of a particulargroup of tests with different criteria depending on which location thetests have been done. The disclosed laboratory system can include bothautomatic validation performed by the system and manual validation bythe user. The manual validation system can allow the user to select agroup of tests of one or more locations and validate them with aspecific test result validation criterion. In the end, the system—basedon the location of the test—may apply an automatic validation of resultsbased on remotely defined criteria. This automatic validation cantrigger the sending of results for clinical validation or, in othercases, the emission of the report with the validated results.

The laboratory system may further comprise work areas defined for eachof the laboratories. The work areas can be different from one anotherwith respect to the analytical tests performable by the laboratories.The test result validation criteria can be allocated to the work areas.

Thus, the test result validation criteria may not only be assigned to arespective laboratory but may be assigned to a sub-level location orsubdivision of a target operation. Thereby, the test result validationcriteria may be designed to even smaller details or entities of alaboratory.

The work areas may be defined so as to comprise selective ones of theplurality of laboratories and/or subdivisions of the plurality oflaboratories. Thus, each laboratory may be assigned to predeterminedlaboratories which in turn may be divided into several differentlocations. Thus, the work areas may be individually designed.

The test result validation criteria within a single work area may beidentical. Thus, for a respective one of the work area, the samecriteria can apply which can facilitate the validation.

The remote computer may be configured to allow a user to manuallyperform validation of groups of the analytical test results. Thus, auser may individually define the analytical test results to bevalidated.

The remote computer may be configured to allow a user to select groupsof the analytical test results to be validated. Thus, the user mayindividually select the analytical test results to be validated.

The remote computer may be configured to adjust the test resultvalidation criteria based on a validation criteria adjustment schedule.Thus, the test result validation criteria may be adjusted if desired. Itcan be noted that test result validation criteria may be clinical,technical or both.

The laboratories may be spatially separated from one another and whereinthe plurality of profiles of validation criteria may be assigned togeographical locations of corresponding laboratories. Thus, with thedisclosed laboratory system, even laboratories spaced apart from oneanother, even with large distances, can provide or accomplish the abovedescribed advantages.

According to the disclosed computer implemented method for validating agroup of analytical test results of a plurality of analytical tests ofbiological samples performed by analytical instruments of a plurality oflaboratories is presented. The method can comprise defining test resultvalidation criteria for validating at least one of the analytical testresults associated with the respective one of the laboratories,performing analytical tests of biological samples by at least one of theanalytical instruments of the laboratories and defining profiles of testresult validation criteria. Each profile can comprise one or more testresult validation criteria, a predetermined grouping of the plurality ofanalytical tests and a validation group flag indicating a group ofanalytical test results to be validated. The method can also compriseassigning the profiles of validation criteria to one or more of theplurality of laboratories and performing an automatic validation ofgroups of the analytical test results by the remote computer accordingto the profiles of validation criteria by setting the validation groupflag to the groups of analytical test results to be validated andvalidating the groups of tests onto which the validation group flag isset based on the test result validation criteria.

According to the disclosed computer-readable medium, thecomputer-readable medium can store instructions thereon which whenexecuted by a computer system make the computer system perform themethod described above.

According to the disclosed computer program product, the computerprogram product can have program code, in order to perform the methoddescribed above.

The disclosed system/method can further disclose and propose a computerprogram including computer-executable instructions for performing themethod according to the disclosed system in one or more of theembodiments enclosed herein when the program is executed on a computeror computer network. Specifically, the computer program may be stored ona computer-readable data carrier. Thus, specifically, one, more than oneor even all of the method steps as indicated above may be performed byusing a computer or a computer network, particularly by using a computerprogram.

The disclosed system/method can further disclose and propose a computerprogram product having program code, in order to perform the methodaccording to the disclosed system in one or more of the embodimentsenclosed herein when the program is executed on a computer or computernetwork. Specifically, the program code may be stored on acomputer-readable data carrier.

Further, the disclosed system/method can disclose and propose a datacarrier having a data structure stored thereon, which, after loadinginto a computer or computer network, such as into a working memory ormain memory of the computer or computer network, may execute the methodaccording to one or more of the embodiments disclosed herein.

The disclosed system/method can further propose and disclose a computerprogram product with program code stored on a machine-readable carrier,in order to perform the method according to one or more of theembodiments disclosed herein, when the program is executed on a computeror computer network. As used herein, a computer program product canrefer to the program as a tradable product. The product may generallyexist in an arbitrary format, such as in a paper format, or on acomputer-readable data carrier. Specifically, the computer programproduct may be distributed over a data network.

Finally, the disclosed system/method can propose and disclose amodulated data signal which can contain instructions readable by acomputer system or computer network, for performing the method accordingto one or more of the embodiments disclosed herein.

Referring to the computer-implemented aspects of the disclosedsystem/method, one or more of the method steps or even all of the methodsteps of the method according to one or more of the embodimentsdisclosed herein may be performed by using a computer or computernetwork. Thus, generally, any of the method steps including provisionand/or manipulation of data may be performed by using a computer orcomputer network. Generally, these method steps may include any of themethod steps, typically except for method steps requiring manual work,such as providing the samples and/or certain aspects of performing theactual measurements.

Specifically, the disclosed system can further disclose:

a computer or computer network comprising at least one processor,wherein the processor is adapted to perform the method according to oneof the embodiments described,

a computer loadable data structure adapted to perform the methodaccording to one of the embodiments described while the data structureis executed on a computer,

a computer program, wherein the computer program is adapted to performthe method according to one of the embodiments described while theprogram is executed on a computer,

a computer program comprising a program for performing the methodaccording to one of the embodiments described while the computer programis executed on a computer or on a computer network,

a computer program comprising a program according to the precedingembodiment, wherein the program is stored on a storage medium readableto a computer,

a storage medium, wherein a data structure is stored on the storagemedium and wherein the data structure is adapted to perform the methodaccording to one of the embodiments described after having been loadedinto a main and/or working storage of a computer or of a computernetwork, and

a computer program product having program code, wherein the program codecan be stored or is stored on a storage medium, for performing themethod according to one of the embodiments described, if the programcode is executed on a computer or on a computer network.

A laboratory system can comprise a plurality of laboratories. Eachlaboratory can comprise one or more analytical instruments forperforming a plurality of analytical tests of biological samples andprovide analytical test results. The laboratory system can also comprisea remote computer communicatively connected to the laboratories via acommunication network. Each of the laboratories can be configured todefine test result validation criteria for validating at least one ofthe analytical test results associated with the respective analyticaltests of one of the plurality of laboratories. The remote computer canbe configured to define a plurality of profiles of validation criteria.Each profile can comprise a plurality of test result validationcriteria, a predetermined grouping of the plurality of analytical testsand a validation group flag indicating a group of analytical testresults to be validated. The remote computer can be configured to assignthe profiles of validation criteria to one or more of the plurality oflaboratories. The remote computer can be configured to perform anautomatic validation of groups of the analytical test results accordingto the profiles of validation criteria by setting the validation groupflag to the groups of analytical test results to be validated andvalidating the groups of analytical test results onto which thevalidation group flag is set based on the test result validationcriteria.

The laboratory system can further comprise work areas defined for eachof the laboratories. The work areas can be different from one anotherwith respect to the analytical tests performable by the laboratories.The test result validation criteria can be allocated to the work areas.

The work areas can be defined so as to comprise selective ones of theplurality of laboratories and/or subdivisions of the plurality oflaboratories.

The test result validation criteria within a single work area can beidentical.

The remote computer can be configured to allow a user to manuallyperform validation of groups of the analytical test results.

The remote computer can be configured to allow a user to select groupsof the analytical test results to be validated.

The remote computer can be configured to adjust the test resultvalidation criteria based on a validation criteria adjustment schedule.

The laboratories can be spatially separated from one another. Theplurality of profiles of validation criteria can be assigned togeographical locations of corresponding laboratories.

A computer implemented method for validating a group of analytical testresults of a plurality of analytical tests of biological samplesperformed by analytical instruments of a plurality of laboratories cancomprise defining test result validation criteria for validating atleast one of the analytical test results associated with the respectiveone of the laboratories, performing analytical tests of biologicalsamples by one of the analytical instruments of the laboratories, anddefining profiles of test result validation criteria. Each profile cancomprise one or more test result validation criteria, a predeterminedgrouping of the plurality of analytical tests and a validation groupflag indicating a group of analytical test results to be validated. Themethod can also comprise assigning the profiles of validation criteriato one or more of the plurality of laboratories and performing anautomatic validation of groups of the analytical test results by theremote computer according to the profiles of validation criteria bysetting the validation group flag to the groups of analytical testresults to be validated and validating the groups of tests onto whichthe validation group flag is set based on the test result validationcriteria.

A computer-readable medium storing instructions thereon which whenexecuted by a computer system make the computer system perform the stepsof the above method.

A computer program product having program code to perform the abovemethod.

As used in the following, the terms “have”, “comprise” or “include” orany arbitrary grammatical variations thereof can be used in anon-exclusive way. Thus, these terms may both refer to a situation inwhich, besides the feature introduced by these terms, no furtherfeatures are present in the entity described in this context and to asituation in which one or more further features are present. As anexample, the expressions “A has B”, “A comprises B” and “A includes B”may both refer to a situation in which, besides B, no other element ispresent in A (i.e. a situation in which A solely and exclusivelyconsists of B) and to a situation in which, besides B, one or morefurther elements are present in entity A, such as element C, elements Cand D or even further elements.

Further, it can be noted that the terms “at least one”, “one or more” orsimilar expressions indicating that a feature or element may be presentonce or more than once typically will be used only once when introducingthe respective feature or element. In the following, in most cases, whenreferring to the respective feature or element, the expressions “atleast one” or “one or more” may not be repeated, non-withstanding thefact that the respective feature or element may be present once or morethan once.

Further, as used in the following, the terms “particularly”, “moreparticularly”, “specifically”, “more specifically” or similar terms canbe used in conjunction with additional/alternative features, withoutrestricting alternative possibilities. Thus, features introduced bythese terms can be additional/alternative features and are not intendedto restrict the scope of the claims in any way. The present disclosuremay, as the skilled person will recognize, be performed by usingalternative features. Similarly, features introduced by “in anembodiment” or similar expressions can be intended to beadditional/alternative features, without any restriction regardingalternative embodiments, without any restrictions regarding the scopeand without any restriction regarding the possibility of combining thefeatures introduced in such way with other additional/alternative ornon-additional/alternative features.

The term “laboratory system” as used herein can refer to an assembly ofat least two laboratories. The term “laboratory” in turn as used hereincan refer to a facility that provides controlled conditions in whichscientific or technological research, experiments, and measurements maybe performed.

The term “analytical instrument” as used herein can refer to a deviceconfigured to obtain a measurement value and may also be calledanalyzer. An analytical instrument can be operable to determine viavarious chemical, biological, physical, optical or other technicalprocedures a parameter value of the sample or a component thereof. Ananalytical instrument may be operable to measure the parameter of thesample or of at least one analyte and return the obtained measurementvalue. The list of possible analysis results returned by the analyticalinstrument can comprise, without limitation, concentrations of theanalyte in the sample, a digital (yes or no) result indicating theexistence of the analyte in the sample (corresponding to a concentrationabove the detection level), optical parameters, DNA or RNA sequences,data obtained from mass spectroscopy of proteins or metabolites andphysical or chemical parameters of various types. An analyticalinstrument may comprise units assisting with the pipetting, dosing, andmixing of samples and/or reagents. The analytical instrument maycomprise a reagent holding unit for holding reagents to perform theassays. Reagents may be arranged for example in the form of containersor cassettes containing individual reagents or group of reagents, placedin appropriate receptacles or positions within a storage compartment orconveyor. It may comprise a consumable feeding unit. The analyticalinstrument may comprise a process and detection system whose workflowcan be optimized for certain types of analysis. Examples of suchanalytical instruments can be clinical chemistry analyzers, coagulationchemistry analyzers, immunochemistry analyzers, urine analyzers, nucleicacid analyzers, used to detect the result of chemical or biologicalreactions or to monitor the progress of chemical or biologicalreactions.

The term “validation” as used herein can refer to a process of ensuringthat an analytical test result is plausible. It can use routines, oftencalled “validation criteria”, “validation rules” “validationconstraints” or “check routines”, that check for correctness,meaningfulness, and security of data that are included in the analyticaltest result. The criteria may be automatically implemented through theremote computer, or by the inclusion of explicit application programvalidation logic operated by a user. Thus, validation can mean a checkwhether the test result satisfies the validation criterion assignedthereto and it can be said to be invalid or to have failed thevalidation if the test result does not satisfy the validation criterion.

The term “test result validation criteria” as used herein can refer tocriteria used for validating at least one test result of an analyticaltest. The criteria may be a threshold of test result, a range of anacceptable test result or any other aspect allowing to evaluate the testresult.

The term “work area” as used herein can refer to a location to which anoperation or job to be carried out is assigned.

The term “subdivision” as used herein can refer to an entity of alaboratory. For example, a laboratory can be divided into predeterminedsubdivisions. The reason for the provision of subdivisions can exist fororganizational reasons such as the assigning of the performance ofdifferent analytical tests to subdivisions or operational procedures inorder to increase the efficiency of the laboratory output.

The term “sub-level location” as used herein can refer to a location ofa lower level of a certain location. For example, a location may bedivided into even smaller locations. For example, a laboratory may bepresent at a certain location such as a city or building, wherein thesub-level locations of this location can be different locations in thiscity or building.

FIG. 1 shows a laboratory system 100. The laboratory system 100 cancomprise a plurality of laboratories 102. Each laboratory 102 cancomprise one or more analytical instruments 104 for performing aplurality of analytical tests of biological samples and provideanalytical test results. The laboratories 102 can be located atdifferent locations 106. For example, the laboratory system 100 cancomprise four locations 106, each of which can comprise one laboratory102. It can be noted that the number of laboratories 102 may be less ormore than four such as two, three, five, six or even more. The locations106 can be spatially separated from one another. The laboratory system100 can further comprise work areas 108 defined for each of thelaboratories 102. The work areas 108 can be different from one anotherwith respect to the analytical tests performable by the laboratories102. For example, each laboratory 102 can comprise four work areas 108.It can be noted that the number of work areas 108 for each of thelaboratories 102 may be less or more than four such as two, three, five,six or even more. The work areas 108 can be defined so as to compriseselective ones of the plurality of laboratories 102 and/or subdivisionsof the plurality of laboratories 102. Each of the laboratories 102 canbe configured to define test result validation criteria for validatingat least one of the analytical test results associated with therespective analytical tests of one of the plurality of laboratories 102.For example, each laboratory 102 may include a computer having an inputdevice such as a keyboard for inputting the definition of test resultvalidation criteria. The test result validation criteria within a singlework area 108 can be identical. The test result validation criteria maybe allocated to the work areas 108.

The laboratory system 100 can further comprise a remote computer 110communicatively connected to the laboratories 102 via a communicationnetwork 112. The communication network 112 may include a wired orwireless connection of the remote computer 110 and the laboratories 102.For example, the communication network 112 may include a connection bythe world wide web. The remote computer 110 can be configured to definea plurality of profiles P1-n of validation criteria as will be explainedin further detail below. It is to be noted that n is an integer greaterthan 1.

FIG. 2 shows an example for profiles P1-n of validation criteria definedby the remote computer 110. Each profile P1-n can comprise a pluralityof the test result validation criteria C1-n, a predetermined groupingG1-n of the plurality of analytical tests T1-n and a validation groupflag F1-n indicating a group G1-n of analytical test results TR1-n to bevalidated. It can be noted that n is respectively an integer greaterthan 1. The plurality of profiles P1-n of validation criteria can beassigned to geographical locations L1-n of corresponding laboratories102. The remote computer 110 can be configured to assign the profilesP1-n of validation criteria to the one or more of the laboratories 102.The remote computer 110 can be configured to perform an automaticvalidation of groups G1-n of the analytical test results according tothe profiles P1-n of validation criteria by setting the validation groupflag F1-n to the groups G1-n of analytical tests to be validated andvalidating the groups of test results TR-1 n onto which the validationgroup flag F1-n is set based on the test result validation criteriaC1-n. Optionally, each laboratory 102 may be configured to send the testresult validation criteria to the remote computer 110.

As mentioned above, the laboratories 102 can be configured to performplurality of analytical tests by the respective analytical instruments104. In the shown example, six analytical tests T1, T2, T3, T4, T5, T6may be performed. The analytical tests T1-T6 may be grouped. Forexample, profile P1 can comprise a first group G1 and a second group G2.Group G1 can include analytical tests T1, T2, T3 and group G2 includesanalytical tests T4, T5, T6. For group G1, test result validationcriterion C1 can be defined. For group G2, test result validationcriterion C2 can be defined. Profile P1 can be assigned to location L1.Further, profile P2 can comprise a third group G3 and a fourth group G4.Group G3 can include analytical tests T1 and T5 and group G4 can includeanalytical tests T2 and T4. For group G3, test result validationcriterion C3 can be defined. For group G4, test result validationcriterion C4 can be defined. Profile P2 can be assigned to location L2.With this configuration, the laboratory system 100 may operate so thatthe analytical test T1 at location L1 can be validated using test resultvalidation criterion C1 whereas the analytical test T1 at location L2can be validated using criteria C2.

The remote computer 110 can be configured to allow a user to manuallyperform validation of groups of the analytical test results TR1-n.Further, the remote computer 110 can be configured to allow a user toselect groups G1-n of the analytical test results TR1-n to be validated.The remote computer 110 can be configured to adjust the test resultvalidation criteria C1-n based on a validation criteria adjustmentschedule. The test result validation criteria C1-n may be clinical,technical or both.

FIG. 3 shows examples for the allocation of test result validationcriteria C1-n to work areas WA1-n. It can be noted that n is an integergreater than 1. As mentioned above, the work areas WA1-n can bedifferent from one another with respect to the analytical testsperformable by the laboratories 102. The work areas WA1-n can be definedso as to comprise selective ones of the plurality of laboratories 102and/or subdivisions of the plurality of laboratories. The test resultvalidation criteria C1-n within a single work area WA1-n can beidentical. FIG. 3 shows a first work area WA1 to which a group G1 ofthree analytical tests T1, T2, T3 is allocated. The analytical tests T1,T2, T3 may be performed at location L1 for which test result validationcriterion C1 is defined. FIG. 3 also shows a second work area WA2 towhich the group G1 of three analytical tests T1, T2, T3 is allocated.The analytical tests T1, T2, T3 may be performed at location L2 forwhich test result validation criterion C2 is defined. With thisconfiguration, for example, the test result TR1 of test T1 in locationL1 can be validated using the test result validation criterion C1,whereas the test result TR1 of test T1 in location L2 can be validatedusing the test result validation criterion C2.

FIG. 4 shows a block diagram of an operation carried out by thelaboratory system 100. A profile P1 of test result validation criteriais defined in that the profile P1 can include test result validationcriteria C1, C2, C3 assigned to groups G1, G2, G3. The laboratories 102may perform analytical tests T1, T2, T3, T4, T5, T6, the results TR1,TR2, TR3, TR4, TR5, TR6 of which are all to be validated at the sametime. Analytical tests T1 and T2 can be assigned to group G1. Analyticaltests T3 and T4 can be assigned to group G2. Analytical tests T5 and T6can be assigned to group C3. An order 114 for validating all resultsTR1-6 of the analytical tests T1, T2, T3, T4, T5, T6 may be validatedwith the profile P1. In other words, only one step may be necessary tovalidate the complete order 114 and reveal the validation result 116.

FIG. 5 shows a swim line diagram a method 118 for validating a groupG1-n of analytical test results TR1-n of a plurality of analytical testsT1-n of biological samples performed by analytical instruments 104 of aplurality of laboratories 102. The method may be computer implemented.For example, the method 118 can be performed by the remote computer 110described above.

The method 118 can comprise the following basic steps which will beexplained in further detail with reference to FIGS. 6 to 10. It can benoted that the method will be explained as an example only assuming thattwo laboratories 102 are present with the laboratory system. Thus, itcan be clear that more than two laboratories 102 may be present such asthree, four, five or even more laboratories 102. One of the twolaboratories 102 can be located at a first location L1 and the other onecan be located at a second location L2 different from the first locationL1. Step 120 can include defining test result validation criteria C1-nfor validating at least one of the analytical test results TR1-nassociated with the respective one of the laboratories 102. Thevalidation criteria C1-n may be defined by the laboratories 102. Step122 can include performing analytical tests T1-n of biological samplesby one of the analytical instruments 104 of the laboratories 102. Step124 can include defining profiles P1-n of test result validationcriteria. The profiles P1-n may be defined by the remote computer 110.Each profile P1-n can comprise one or more test result validationcriteria C1-n, a predetermined grouping G1-n of the plurality ofanalytical tests T1-n and a validation group flag F1-n indicating agroup of analytical test results TR1-n to be validated. Step 126 caninclude assigning the profiles P1-n of test result validation criteriaC1-n to the one or more of the laboratories 102. Step 128 can includeperforming an automatic validation of groups G1-n of the analytical testresults TR1-n according to the profiles P1-n of test result validationcriteria C1-n by setting the validation group flag F1-n to the groupsG1-n of analytical test results TR1-n to be validated and validating thegroups G1-n of analytical tests T1-n onto which the validation groupflag F1-n is set based on the test result validation criteria C1-n. Theautomatic validation may be performed by the remote computer 110.

FIG. 6 shows a swim line diagram of step 120 of the above method. Asmentioned above, one of the two laboratories 102 can be located at firstlocation L1 and the other laboratory 102 can be located at secondlocation L2. The laboratory 102 at first location L1 can be configuredto perform six analytical tests T1, T2, T3, T4, T5, T6 resulting in theanalytical test results TR1, TR2, TR3, TR4, TR5, TR6. The laboratory 102at second location L2 can be configured to perform four analytical testsT1, T2, T4, T5 resulting in the TR1, TR2, TR4, TR5. Step 120 can includesub-step 130 in which the laboratory 102 at location L1 can select theanalytical test results TR1, TR2, TR3, TR4, TR5, TR6 for process ofdefining test result validation criteria C1-n. In sub-step 132, thelaboratory 102 at location L1 can define two validation criteria C1, C2.In sub-step 134, the laboratory 102 at location L1 can communicate thedefined validation criteria C1, C2 to the remote computer 110. Forexample, the laboratory 102 at location L1 can send data includinginformation on the validation criteria C1, C2 to the remote computer 110via the communication network 112. Step 120 can also include sub-step136 in which the laboratory 102 at location L2 can select the analyticaltest results TR1, TR2, TR4, TR5 for process of defining test resultvalidation criteria C1-n. In sub-step 138, the laboratory 102 atlocation L2 can define two validation criteria C3, C4. In sub-step 140,the laboratory 102 at location L2 can communicate the defined validationcriteria C3, C4 to the remote computer 110. For example, the laboratory102 at location L2 can send data including information on the validationcriteria C3, C4 to the remote computer 110 via the communication network112. It can be noted that steps 130 to 134 and steps 136 to 140 may becarried out in a subsequent or simultaneous manner.

FIG. 7 shows a swim line diagram of step 122 of the above method. Asmentioned above, the laboratory 102 at first location L1 can beconfigured to perform six analytical tests T1, T2, T3, T4, T5, T6, whichcan result in the analytical test results TR1, TR2, TR3, TR4, TR5, TR6.The laboratory 102 at second location L2 can be configured to performfour analytical tests T1, T2, T4, T5, which can result in the TR1, TR2,TR4, TR5. Step 122 can include sub-step 142 in which the laboratory 102at location L1 can perform the analytical tests T1, T2, T3, T4, T5, T6by its analytical instruments 104. In sub-step 144, the analyticalinstruments 104 of laboratory 102 at location L1 can provide therespective analytical test results TR1, TR2, TR3, TR4, TR5, TR6. Insub-step 146, the laboratory 102 at location L1 can communicate theanalytical test results TR1, TR2, TR3, TR4, TR5, TR6 to the remotecomputer 110. For example, the laboratory 102 at location L1 can senddata including information on the analytical test results TR1, TR2, TR3,TR4, TR5, TR6 to the remote computer 110 via the communication network112. Step 122 can also include sub-step 148 in which the laboratory 102at location L2 can perform the analytical tests T1, T2, T4, T5 by itsanalytical instruments 104. In sub-step 150, the analytical instruments104 of laboratory 102 at location L2 can provide the respectiveanalytical test results TR1, TR2, TR4, TR5. In sub-step 152, thelaboratory 102 at location L2 can communicate the analytical testresults TR1, TR2, TR4, TR5 to the remote computer 110. For example, thelaboratory 102 at location L2 can send data including information on theanalytical test results TR1, TR2, TR4, TR5 to the remote computer 110via the communication network 112. It can be noted that steps 142 to 146and steps 148 to 152 may be carried out in a subsequent or simultaneousmanner.

FIG. 8 shows a flow chart of step 124 of the above method. Step 124 caninclude sub-step 154, in which the remote computer 110 can select testresult validation criteria C1-n for the process of defining a profileP1-n of the test result validation criteria C1-n. In the shown example,the remote computer 110 can select test result validation criteria C1,C2, C3, C4 provided by the laboratories 102 at locations L1, L2. Insub-step, 156, the remote computer 110 can create groups G1-n ofanalytical tests T1-n. In the shown example, the remote computer 110 cancreate group G1 including analytical tests T1, T2, T3, group G2including analytical tests T4, T5, T6, group G3 including analyticaltests T1, T5 and group G4 including T2, T4. In sub-step 158, the remotecomputer 110 can create group flags F1-n indicating a group G1-n ofanalytical test results TR1-n to be validated. In the shown example, theremote computer 110 can create group flag F1 including the analyticaltest results of group G1, group flag F2 including the analytical testresults of group G2, group flag F3 including the analytical test resultsof group G3 and group flag F4 the analytical test results of group G4.Thereby, in sub-step 160, a profile P1 of test result validationcriteria comprising test result validation criteria C1, C2, groups G1,G2 and group flags F1, F2, and a profile P2 of test result validationcriteria comprising test result validation criterion C3, C4, groups G3,G4 and group flags F3, F4, can be defined.

FIG. 9 shows a flow chart of step 126 of the above method. Step 126 caninclude sub-step 162, in which profile P1 of test result validationcriteria can be assigned to the laboratory 102 at location L1, and substep 164, in which profile P2 of test result validation criteria can beassigned to the laboratory 102 at location L2. It can be noted thatsteps 162 and 164 may be carried out in a subsequent or simultaneousmanner.

FIG. 10 shows a flow chart of step 128 of the above method. Step 128 caninclude sub-step 166, in which the validation group flag F1-n is set tothe groups G1-n of analytical test results TR1-n to be validated. In theshown example, group flag F1 can be set onto group G1, group flag F2 canbe set onto group G2, group flag F3 can be set onto group G3 and groupflag F4 can be set onto group G4. In sub-step 168, the groups G1-n ofanalytical test results TR1-n onto which the validation group flag F1-nis set can be validated based on the test result validation criteriaC1-n. In the shown example, group G1 can be validated based on testresult validation criterion C1, group G2 can be validated based on basedon test result validation criterion C2, group G3 can be validated basedon based on test result validation criterion C3 and group G4 can bevalidated based on based on test result validation criterion C4. Insub-step 170, the result of the automatic validation of the groups G1-nof analytical test results TR1-n can be provided. With other words, eachof the analytical test results TR1-n can be checked whether it satisfiesthe validation test result validation criterion C1-n. It can be said tobe invalid if the analytical test result does not satisfy the associatedvalidation criterion C1-n. In the shown example, analytical test resultsTR1, TR2, TR3 of group G1 can be validated so as to satisfy test resultvalidation criterion C1 as indicated by “V”, analytical test resultsTR4, TR5, TR6 of group G2 can be validated so as not to satisfy testresult validation criterion C2 as indicated by “X”, analytical testresults TR1, TR5 of group G3 can be validated so as not to satisfy testresult validation criterion C3 as indicated by “X” and analytical testresults TR2, TR4 of group G4 can be validated so as to satisfy testresult validation criterion C4 as indicated by “V”.

FIG. 11 shows another embodiment of the method of FIG. 5. In addition tothe automatic validation in step 128, by the remote computer 110, instep 172 a user may select groups G1-n of the analytical test resultsTR1-n to be validated. In the shown example, a user can select groups G1and G3 in step 172. Thereby, the user may manually perform validation ofgroups G1-n of the analytical test results TR1-n by the remote computer110 in step 174. In the shown example, manual validation of groups G1and G3 can be performed. The remote computer can then provide the userwith the validation result in step 176. In the shown example, group G1can be indicated so as to be valid as indicated by “V” and group G3 isindicated so as not be valid as indicated by “X”.

FIG. 12 shows another embodiment of the method of FIG. 5 which may bemade alternatively or in addition to the one of FIG. 11. Before definingthe profiles P1-n in step 124, the remote computer 110 may adjust thetest result validation criteria C1-n based on a validation criteriaadjustment schedule. For example, in step 178, the remote computer 110can receive the test result validation criteria C1, C2, C3, C4 from thelaboratories 102. In step 180, the remote computer 110 can refer to avalidation criteria adjustment schedule so as to adjust the test resultvalidation criteria C1, C2, C3, C4. In step 182, the remote computer 110can then provide adjusted test result validation criteria C′1-n. In theshown example, the remote computer can adjust test result validationcriteria C1 and C3 so as to provide adjusted test validation testcriteria C′1 and C′3. An adjustment of the test result validationcriteria may be needed due to changes in the analytical tests, changesin the regulatory requirements, changes due to constant improvement ofthe validation criteria, quality control data or a reflex testresult(s).

FIG. 13 shows another embodiment of the method of FIG. 5 which may bemade alternatively or in addition to the ones of FIGS. 11 and 12. Beforeor after defining the test result validation criteria C1-n in step 120,work areas WA1-n can be defined for each of the laboratories 102. Forexample, in step 184 four work areas WA1, WA2, WA3, WA4 can be defined.The work areas WA1-n may be defined by the laboratories 102. The workareas WA1, WA2, WA3, WA4 can be different from one another with respectto the analytical tests T1-n performable by the laboratories 102.Particularly, the work areas WA1, WA2, WA3, WA4 can be defined so as tocomprise selective ones of the plurality of laboratories 102 and/orsubdivisions of the plurality of laboratories 102. For example, workarea WA1 can comprise a laboratory 102 configured to perform analyticaltests T1 and T3, work area WA2 can comprise a laboratory 102 configuredto perform analytical tests T2 and T4, work area WA3 can comprise alaboratory 102 configured to perform analytical tests T3 and T5 and workarea WA4 can comprise a laboratory 102 configured to perform analyticaltests T1 and T6. The test result validation criteria C1-n within asingle work area WA1-n can be identical. For example, test resultvalidation criteria C1 and C3 in work area WA1 can be identical. In step186, the test result validation criteria C1-n can be allocated to thework areas WA1-n. For example, test result validation criteria C1 and C3can be allocated to work area WA1, test result validation criteria C2and C3 can be allocated to work area WA2, test result validationcriteria C1 and C4 can be allocated to work area WA3 and test resultvalidation criteria C2 and C4 can be allocated to work area WA4.

It is noted that terms like “preferably,” “commonly,” and “typically”are not utilized herein to limit the scope of the claimed embodiments orto imply that certain features are critical, essential, or evenimportant to the structure or function of the claimed embodiments.Rather, these terms are merely intended to highlight alternative oradditional features that may or may not be utilized in a particularembodiment of the present disclosure.

Having described the present disclosure in detail and by reference tospecific embodiments thereof, it will be apparent that modifications andvariations are possible without departing from the scope of thedisclosure defined in the appended claims. More specifically, althoughsome aspects of the present disclosure are identified herein aspreferred or particularly advantageous, it is contemplated that thepresent disclosure is not necessarily limited to these preferred aspectsof the disclosure.

I claim:
 1. A laboratory system, the laboratory system comprising: aplurality of laboratories, each laboratory comprising one or moreanalytical instruments performing a plurality of analytical tests ofbiological samples and providing analytical test results, wherein theone or more of analytical instruments of each laboratory is configuredto define test result validation criteria for validating at least one ofthe analytical test results associated with respective to the analyticaltests of one or more of the plurality of laboratories; and a remotecomputer communicatively connected to the laboratories via acommunication network, wherein the remote computer is configured to:define a plurality of profiles of validation criteria, each profilecomprising a plurality of test result validation criteria, wherein theplurality of the test result validation criteria are allocated to workareas, wherein the work areas defined for the each of the laboratoriesand are different from one another with respect to the analytical testsperforming by the one or more analytical instruments of thelaboratories, a predetermined grouping of the plurality of analyticaltests, and a validation group flag indicating a group of analytical testresults to be validated; assign the profiles of test result validationcriteria to the one or more of the plurality of laboratories; perform anautomatic validation of groups of the analytical test results based onthe profiles of the test result validation criteria by setting thevalidation group flag (F1-n) to the groups of the analytical testresults to be validated and validating the groups of the analytical testresults onto which the validation group flag is set based on the testresult validation criteria; the remote computer further configured toallow a user to manually perform the validation of the groups of theanalytical test results by defining, selecting the analytical testresults to be validated, and adjusting the test results validationcriteria if desired; and thereby increasing quality of the analyticaltest results and providing consistency in the validation of test resultsacross multiple laboratories.
 2. The laboratory system according toclaim 1, wherein the work areas are defined so as to comprise selectiveones of the plurality of laboratories and/or subdivisions of theplurality of laboratories.
 3. The laboratory system according to claim1, wherein the test result validation criteria within a single work areaare identical.
 4. The laboratory system according to claim 1, whereinthe laboratories are spatially separated from one another and whereinthe plurality of profiles of validation criteria are assigned togeographical locations of corresponding laboratories.
 5. A computerimplemented method for validating a group of analytical test results ofa plurality of analytical tests of biological samples performed byanalytical instruments of a plurality of laboratories, the methodperformed by a remote computer connected to the laboratories via acommunication network, comprising: defining test result validationcriteria for validating at least one of the analytical test resultsassociated with respective one or more of the laboratories; performingthe analytical tests of the biological samples by one or more of theanalytical instruments of the laboratories; defining profiles of thetest result validation criteria, each profile comprising one or moretest result validation criteria, wherein the one or more test resultvalidation criteria are allocated to work areas, wherein the work areasdefined for the each of the laboratories and are different from oneanother with respect to the analytical tests performing by the one ormore of the analytical instruments of the laboratories, a predeterminedgrouping of the plurality of analytical tests and a validation groupflag (F1-n) indicating a group of the analytical test results to bevalidated; assigning the profiles of the test result validation criteriato the one or more of the laboratories; performing an automaticvalidation of groups of the analytical test results based on theprofiles of the validation criteria by setting the validation group flag(F1-n) to the groups of the analytical test results to be validated andvalidating the groups of the analytical test results onto which thevalidation group flag is set based on the test result validationcriteria; the remote computer further configured to allow a user tomanually perform the validation of the groups of the analytical testresults by defining, selecting the analytical test results to bevalidated and adjusting the test results validation criteria as desired;and thereby increasing quality of the analytical test results andproviding consistency in the validation of test results across multiplelaboratories.
 6. A non-transitory computer-readable medium storinginstructions thereon which when executed by a computer system make thecomputer system perform the method according to claim 5.